Instructions for toxic traditional Chinese Medicine
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Last Update: 2013-11-20
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Source: Internet
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Author: User
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Recently, the State Food and Drug Administration (CFDA) issued the "notice on Revising the product specifications of Chinese patent medicines containing toxic Chinese Herbal Pieces" (hereinafter referred to as the "notice"), and the product specifications of several drugs under Guangzhou Baiyunshan, Tongrentang, Tonghua Jinma and other enterprises were required to be modified Pharmacists pointed out that the biggest significance of the revision of the manual is to protect the patients' right to know 28 kinds of toxic traditional Chinese medicine need to add warning words According to the notice, where the prescription contains the Chinese patent medicine varieties (including toxic processed products) made of 28 kinds of toxic medicinal materials collected in the measures for the administration of toxic drugs for medical use (Order No 。 It is reported that the notice of revising the manual of Chinese patent medicine involves a number of drugs owned by a number of pharmaceutical companies According to the relevant person in charge of Tonghua Jinma, there are four kinds of drugs involved in the revision of the product manual, including Radix Aconiti in the Panax notoginseng tablet The ingredients of Liuling pill of Tongrentang and Huoxin pill of Baiyunshan Pharmaceutical Factory in Guangzhou contain toad The reporter also found in the interview that the ingredient specification of the commonly used medicine Huoxiang Zhengqi water included raw pinellia, but it was not specified in the drug specification It is also required in the notice of filing before the end of December that the relevant pharmaceutical manufacturers shall submit the supplementary application for revising the manual for filing before December 31, 2013 It is understood that the pharmaceutical enterprises involved in the revision only need to submit an application with the food and Drug Administration of the province where the enterprise is located for filing The reporter called Baiyunshan Pharmaceutical General Factory in Guangzhou The head of the company's quality assurance department said that the company is preparing application materials according to the requirements The head of Tonghua Jinma quality assurance department said: "our company's internal materials are ready and waiting to be submitted for filing However, it is inconvenient to travel in the Northeast due to heavy snow recently, which delays the filing work, but we will definitely submit them as required." As of the press release, Tongrentang's phone has been shut down The notice also requires that, in addition to the above 28 toxic traditional Chinese medicine varieties, the prescription contains other traditional Chinese medicine varieties that have been proved to be toxic and easy to cause serious adverse reactions, and relevant drug manufacturers should also revise the instructions according to the above requirements, such as anti-inflammatory and cholagogic tablets containing Kuki After the issuance of the notice, CFDA issued the notice on "revision of the instructions of Xiaoyan Lidan tablets", requiring that the notice of "the bitter wood contained in this product has little poison, so it is not suitable to take it for a long time" should be added to the instructions of this drug At the same time, the adverse reactions and precautions were also not clear before, adding adverse reactions including nausea, vomiting, abdominal pain, anaphylactic shock, general convulsion and so on.
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